Z-0716-2020Class II

Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J

Name: Z-0716-2020 Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Creator: Arrow International Inc
Published: 2019-11-15
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2019-11-15 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J on 2019-11-15. FDA classified it as Class II and gives the reason as "Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0716-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-15
Posted: 2019-12-19
Terminated: 2020-06-19
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Product code: DYG Catheter, Flow Directed
Reason for recall: Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Arrow International issued letters on 11/15/19 stating reason for recall, health risk, and action to take: immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To acknowledge receipt of this Urgent Medical Device Recall Notice or to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1- 855-419-8507, Attn: Customer Service or ema il [email protected]. your local sales representative or Customer Service at 1-866-396-2111. .
Quantity in commerce: 1 unit
Distribution: U.S. Nationwide, Canada
Product codes and lots: Lot Number: 16F19H0093

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0716-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0715-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-19
Z-0716-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-19

Product code DYG

K892530Class IICatheters for Balloon Occlusion Femoral AngiographArrow Intl., Inc. / cleared 1989-09-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)